Clinical Trials Register

Summary
EudraCT Number:	2020-005059-19
Sponsor's Protocol Code Number:	C0921062
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-02-05
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2020-005059-19

A.3

Full title of the trial

A PHASE 3B, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX® IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

BADANIE FAZY 3B PROWADZONE METODĄ OTWARTEJ PRÓBY OCENIAJĄCE BEZPIECZEŃSTWO I IMMUNOGENNOŚĆ SZCZEPIONKI NIMENRIX® U ZDROWYCH NIEMOWLĄT PODAWANEJ W 3. I 12. MIESIĄCU ŻYCIA

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A PHASE 3B, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX® IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

Badanie fazy 3B prowadzone metodą otwartej próby dotyczące dwóch dawek szczepionki Nimenrix u niemowląt

A.4.1

Sponsor's protocol code number

C0921062

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc., 235 East 42nd Street, New York, NY 10017
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pfizer Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Call Centre
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+18007181021
B.5.6	E-mail	ClinicalTrials.gov_Inquiries@pfizer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Nimenrix®
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Europe MA EEIG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder and solution for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Neisseria meningitidis group A polysaccharide
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36479
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Neisseria meningitidis group C polysaccharide
D.3.9.3	Other descriptive name	N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID
D.3.9.4	EV Substance Code	SUB26116
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Neisseria meningitidis group W-135 polysaccharide
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36481
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Neisseria meningitidis group Y polysaccharide
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36482
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Invasive Meningococcal Disease (IMD)

E.1.1.1

Medical condition in easily understood language

Prevention of disease caused by a type of bacteria called NeisseriaI

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10076062
E.1.2	Term	Meningococcal immunization
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Safety
•To describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.
Immunogenicity
•To describe the immune response for Neisseria meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

E.2.2

Secondary objectives of the trial

1. To describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age.
2. To describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
3. To further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age and Sex:
1.Male or female infants born at >36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1).
Type of Participant and Disease Characteristics:
2.Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
3.Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
4.Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.

E.4

Principal exclusion criteria

Medical Conditions:
1.A previous anaphylactic reaction to any vaccine or vaccine-related component.
2.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
3.History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
4.Significant neurological disorder or history of seizure (including simple febrile seizure).
5.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
6.Family history of congenital or hereditary immunodeficiency.
7.Other medical or psychiatric condition, including recent or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
8.Major known congenital malformation or serious chronic disorder.
Prior/Concomitant Therapy:
9.Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y. Written vaccination history must be obtained prior to enrollment.
10.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
11.Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date on enrollment (first vaccination).
12.Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent. Inhaled and topical steroids are allowed.
Prior/Concurrent Clinical Study Experience:
13.Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
Diagnostic Assessments:
Not applicable.
Other Exclusions:
14.Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

E.5 End points

E.5.1

Primary end point(s)

Safety
•Local reactions (redness, swelling, and pain at the injection site).
•Systemic events (fever, decreased appetite, drowsiness, and irritability).
•AEs.
•SAEs.
•NDCMCs.
Immunogenicity
•rSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups.

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety
• % of participants (P) reporting local reactions, systemic events, and use of antipyretic medication within 7 days after Dose 2 (Visit 3) of Nimenrix (IMP)
•% of P reporting at least 1 AE, at least 1 SAE, and at least 1 NDCMC during the 30 days after Dose 2 (Visit 3) of IMP.
•% of P reporting at least 1 immediate AE after Dose 2 (Visit 3) of IMP
Immunogenicity
•% of P with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at baseline (Visit 1), at 1 month after Dose 1 (Visit 2), at Dose 2 (Visit 3) and at 1 month after Dose 2 (Visit 4) of IMP
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at baseline (Visit 1), at 1 month after Dose 1 (Visit 2), at Dose 2 (Visit 3), at 1 month after Dose 2 (Visit 4) of IMP

E.5.2

Secondary end point(s)

1.
•Local reactions (redness, swelling, and pain at the injection site).
•Systemic events (fever, decreased appetite, drowsiness, and irritability).
•AEs.
•SAEs.
•NDCMCs.
2.
•rSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups.
•hSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups.
3.
•hSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups.
•rSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix, within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix, immediately after Visit 1, (3 months of age), from 1 month after Dose 1 (Visit 2, 4 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix; from Dose 1 (Visit 1, 3 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix.
2. baseline (Visit 1, 3 months of age) and at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix.
3. baseline (Visit 1, 3 months of age), at 1 month after Dose 1 (Visit 2, 4 months of age), at Dose 2 (Visit 3, 12 months of age), and at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix.
More information is available in the Protocol

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

150

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

150

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

3 months and 12 months old therefore incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No intervention will be provided to study participants at the end of the study

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-05-12

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-09-09

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